Headwear for use in applying cold to a person&#39;s scalp

ABSTRACT

Headwear (2) for use in applying cold to a person&#39;s scalp, which headwear (2) is flat when it is not being worn, is foldable around a person&#39;s head (4) when it is being worn, and is securable on the person&#39;s head (4), by a plurality of fastener means (6), the headwear (2) being such that the folding nature of the headwear (2) and the plurality of fastener means (6) enables the headwear (2) to be folded as a close fit on the person&#39;s head (4) irrespective of different persons with different shapes and sizes of head, and the headwear (2) being such that is has double skinned portions (8, 10) which contain a cold retaining medium which gives up its cold to the person&#39;s scalp when the headwear (2) is being worn.

This invention relates to headwear for use in applying cold to aperson's scalp.

It is medically known that cooling of the scalp is extremely effectivein preventing hair loss induced by drugs given during chemotherapytreatment to cancer patients. The drugs given during chemotherapy areusually cytotoxic drugs. The cooling of the scalp constricts the bloodsupply to hair follicles in the scalp, thereby diminishing or preventingthe hair follicles receiving high cytotoxic drug concentrations duringthe initial phases of chemotherapy. Furthermore, the coldness itselfreduces the metabolism of cells of the hair follicles and thus reducesthe ability of the cytotoxic drugs to act on the hair follicles. Thecombined effect of constricting the blood supply to the hair folliclesand reducing the metabolism of the cells of the hair follicles preventsor reduces the hair loss.

It is known to cool the scalp by applying cooled gel packs or ice packs.The application of such packs is tedious and an even cooling of thescalp is not able to be achieved. An improved known method of coolingthe scalp is to use an article of headwear like a helmet which containsbetween inner and outer skins a cold retaining medium such as a gel. Theknown helmets are not satisfactory in that they are not able to fitsufficiently snuggly on the heads of different persons, which heads maybe of different sizes and shapes, and which heads may have differentamounts of hair and hairstyles. This is an important disadvantagebecause the helmets are designed for re-use, for example in hospitalsand similar establishments, and a wide variety of patients may need towear the helmets.

It is an aim of the present invention to obviate or reduce the abovementioned problems.

Accordingly, the present invention provides headwear for use in applyingcold to a person's scalp, which headwear is flat when it is not beingworn, is foldable around a person's head when it is being worn, and issecurable on the person's head by a plurality of fastener means, theheadwear being such that the folding nature of the headwear and theplurality of fastener means enables the headwear to be folded as a closefit on the person's head irrespective of different persons withdifferent shapes and sizes of head, and the headwear being such that ithas double skinned portions which contain a cold retaining medium whichgives up its cold to the person's scalp when the headwear is being worn,a chin strap, and a layer of insulating material for helping to preventloss of cold from the headwear to the atmosphere.

The headwear of the present invention is advantageous in that it is ableto be snuggly fitted on different sizes and shapes of head, withdifferent amounts of hair and different types of hairstyles. Theheadwear can be snuggly fitted to give a tight compressive fit. Theheadwear is such that all parts of the head can be covered and the coldcan be evenly distributed. Still further, the headwear can retain thecold better than many known types of headwear so that less numbers ofcooled articles of headwear need to be worn by a patient during a periodof treatment than has hitherto been necessary with many known types ofheadwear. A further advantage of the headwear of the present inventionis that it is portable so that a patient is able to walk about, forexample in order to go to the toilet or to relieve boredom, and thepatient is not permanently connected to a mechanical air coolingmachine. The headwear of the present invention can be produced to be ofa light weight for so that it is not unduly uncomfortable to wear. Thus,for example, the headwear may be produced to weigh from 2 lbs 14 oz to 3lbs 8 oz (1304.1-1587.6 gms)

The headwear may have a pair of straps which connect together to formthe chin strap part of the headwear.

The headwear may have front flaps which connect together to form a partof the headwear for covering the front of the scalp and the temples.Preferably, there are three of the front flaps.

The headwear may have rear flaps which connect together to form a partof the headwear covering the ears, the back of the head and the neck.Preferably, there are five of the rear flaps.

Preferably, the fastener means are of a type having a plurality ofinterlocking plastics members. One type of such fastener means having aplurality of interlocking plastics members is sold under the registeredtrade mark Velcro.

The fastener means may comprise a plurality of pads of the plasticsmembers and an outer surface to the headwear which is such that the padscan fasten to the outer surface, the pads being positioned at edgeportions of the headwear when it is flat, and the headwear being suchthat the pads can be placed where appropriate on the outer surface ofthe headwear to form the headwear into the required shape for fittingclosely on the person's head. When the above mentioned straps and flapsare employed, then the pads will usually be positioned on the straps andthe flaps.

The outer surface of the headwear is preferably a raised looped brushednylon material. A presently preferred material is 125 gms per squaremeter in weight and it is provided with a coat of polyurethane on itsside remote from the raised looped brushed nylon type of material.

The headwear may be such that the double skinned portions form a topcompartment for the cold retaining medium and two side compartments forthe cold retaining medium.

The cold retaining medium is preferably a gel. A presently preferred gelis a glycol gel containing appropriate additives. Thus, for example, theglycol gel may be a pharmaceutical grade polypropylene glycol gelcontaining hydroxypropyl methylcellulose, titanium dioxide and water.The water may be added in a very hot but not boiling state to thepolypropylene glycol and its additives. Alternatively, the water may beadded in a cold state.

The cold retaining medium will usually be sealed inside the headwear,for example in the above mentioned top and two side compartments. Wherethe cold retaining medium is sealed in the headwear, then appropriateseals may be effected by radio frequency sealing. Other methods ofsealing however may be employed.

Generally, the cold retaining medium will be chosen so that it has anoperating temperature range of minus 25° C.-0° C. Also, the coldretaining medium will normally be chosen such that it is able to releaseits cold at a steady rate. By way of example, it is mentioned that whereseveral caps will need to be worn by a patient for a treatment period,then the first cap may be designed to be able to be worn for threequarters of an hour, and subsequent caps may be designed to be worn forone hour each. Such prolonged cold release requires the cold retainingmedium, for example the gel, to be correctly formulated. For example, ifa gel is employed and it is too thin, then the gel heats up too quicklyand the headwear does not give the required amount of cold for therequired period. Conversely, if the gel is too thick it tends to freezeand thus the cap in its flat condition cannot easily be folded to form asnug fit on the person's head.

The headwear may be one in which the double skinned portions are made ofa flexible sheet plastics material which is such that it retains itsflexibility when the headwear is cooled for use on the person's head. Apresently preferred flexible sheet plastics material is polyurethane.Other flexible sheet plastics materials may be employed but care must betaken to ensure that the plastics materials do not tend to crack whenthe headwear is cooled to minus 25° C. For example, polyvinyl chlorideis not really suitable since it tends to crack at minus 15° C. Wherepolyurethane is employed, then the polyurethane flexible sheet plasticsmaterial is preferably 10 gauge.

The headwear may include weld points for use in thinning the coldretaining medium at desired parts of the headwear. The weld points maybe so positioned as to thin the cold retaining medium over parts of theheadwear adjacent the person's forehead and temples. At the weld points,the inner and outer skins of the double skinned portions are connectedtogether.

The headwear may include seams for use in causing the cold retainingmedium evenly to be distributed over the headwear. The seams willusually be welded seams which connect together the inner and outer skinsof the double skinned portions. The inner ends of the seams may beprovided with reinforcing weld points to reinforce the inner ends of theseams. Preferably, there are four of the seams but more or less thanfour of the seams may he employed if desired.

The headwear may include a layer of insulating material for helping toprevent loss of cold from the headwear to the atmosphere. The insulatingmaterial is preferably a foam insulating material or a felt insulatingmaterial. Any suitable and appropriate foam material may be employed.The layer of foam material may be one 0.0625 inch (0.1588 cm) thick. Theinsulating material helps to keep the cold in the cap and helps to stopthe cold retaining medium from being heated by the environment toambient temperature.

The headwear may include holder means for a temperature monitor. Theholder means may be a pocket. If desired, the holder means may beprovided in a head band arrangement which is separate from the headwear.If desired, more than one temperature monitor may be employed so that,for example, up to five temperature monitors may be employed.

The temperature monitor may be connected to a display device which isattached to a person's waist. Such a display device enables thetemperatures monitored by the temperature monitor easily to be seen sothat a close check can be carried out to ensure that the scalp does notrise above the temperature at which scalp cooling will becomeinefficient.

The temperature monitor and the display device may form part of controlmeans for the headwear, for example for controlling how the headwear isused. Thus, for example, the control means may have various visualand/or audible warning systems to ensure that the headwear is initiallyworn for a correct period to bring the scalp to a desired temperatureprior to starting chemotherapy treatment. Too long a period or too shorta period would mean that the scalp was not at the correct temperaturefor the chemotherapy treatment. Also, the control means can be used toindicate an allowed time period for changing the headwear when theheadwear has given up its cold and needs to be replaced by freshheadwear. Further, the control means may indicate the time remaining ona treatment period. Advantageously, the control means is able to storeinformation as to how the headwear has been used, and to be connected toa printer to obtain a hard copy printout of the stored information. Alsoadvantageously, only parts of the stored information are printed, theseparts being selected parts relevant to the use of the headwear, forexample to show when the headwear has not been used properly. Thisavoids generating large printouts.

The headwear of the present invention may be made in different coloursto indicate headwear which will cool to different temperatures and/orwhich will last for different periods of time. The different colours mayalso be used by, for example, nursing staff and doctors, as a means ofindicating whether the headwear is the patient's first, second or thirdetc. article of headwear in any particular course of treatment.

Embodiments of the invention will now be described solely by way ofexample and with reference to the accompanying drawings in which:

FIG. 1 is a view from below of first headwear folded flat;

FIGS. 2-8 show different views from the front to the back and illustratehow the headwear in the flat form shown in FIG. 1 is folded around aperson's head;

FIG. 9 is an enlarged view of half of the flat headwear shown in FIG. 1and illustrates in more detail the construction of the headwear;

FIG. 10 is a section through part of the headwear;

FIG. 11 is a plan view of part of second headwear folded flat;

FIG. 12 is a section through part of the second headwear when it isflat; and

FIG. 13 is a section through part of the second headwear when it is on aperson's head.

Referring to FIGS. 1-10, there is shown headwear 2 for use in applyingcold to a person's scalp. The headwear 2 is flat when it is not beingworn, as shown in FIG. 1. The headwear 2 is foldable around a person'shead 4 when it is being worn, the folding process being illustrated inFIGS. 2-8. The headwear 2 is also such that it is securable on theperson's head 4 by a plurality of fastener means 6.

The headwear 2 is such that the folding nature of the headwear 2 and theplurality of fastener means 6 enables the headwear 2 to be folded as aclose fit on the person's head 4 irrespective of different persons withdifferent sizes and shapes of head. The headwear 2 is also such that ithas double skinned portions 8, 10 which contain a cold retaining mediumwhich gives up its cold to the person's scalp when the headwear 2 isbeing worn.

The headwear 2 comprises a pair of straps 12 which connect together toform a chinstrap part 14 of the headwear 2. The headwear 2 also hasthree front flaps 16 which connect together to form a part 18 of theheadwear for covering the front of the scalp and the temples of theperson's head 4.

The headwear 2 still further has five rear flaps 20 which connecttogether to form a part 22 of the headwear 2 for covering the ears, theback of the head and the neck of the person's head 4.

The fastener means 6 are of the type having a plurality of interlockingplastics members known as Velcro (Registered Trade Mark) These plasticsmembers are in the form of pads 24 as shown most clearly in FIG. 9. Thefastener means also comprises an outer surface 26 to the headwear 2,which outer surface is made of a brushed nylon type of material known asVel-Luch (Registered Trade Mark). This outer surface is such that thepads 24 can be placed where appropriate on the outer surface 26 of theheadwear 2 to form the headwear 2 into the required shape for fittingclosely on the person's head 4. As can be seen from the drawings, thepads 24 are on the ends of the straps 12 and the flaps 16, 20.

The double skinned portions 8, 10 form a top compartment for the coldretaining medium and two side compartments for the cold retainingmedium. The cold retaining medium is preferably a gel. The gel ispreferably a polypropylene glycol gel with additives such ashydroxypropyl methylcellulose and titanium dioxide. The gel is sealed inthe headwear 2 and the various necessary sealing lines are formed byradio frequency welding.

The double skinned portions are made of flexible sheet plastics materialwhich is such that it retains its flexibility when the headwear 2 iscooled down to minus 25° C. This flexible material is 10 gaugepolyurethane material.

As can be seen from FIGS. 1 and 9, the headwear 2 includes weld points28 for use in thinning the cold retaining medium at desired parts of theheadwear 2. More specifically, these weld points 28 are so positioned asto thin the cold retaining medium over parts of the headwear 2 adjacentthe person's forehead and temples.

The headwear 2 contains four seams 29 which terminate at their innerends in reinforcing weld points 30. The seams 29 form interconnectingpockets and they cause the cold retaining medium evenly to bedistributed over the headwear 2. The seams 29 help to prevent the coldretaining medium from sagging when the headwear 2 is being worn. Theweld points 28, 30 and the seams 29 are preferably formed by radiofrequency welding.

The headwear 2 also has seams 31 and 33 which are employed to help tomaintain the cold retaining medium in place and evenly distributedwhilst the headwear 2 is being worn.

FIG. 10 shows the cold retaining medium in the form of a gel 32positioned between inner and outer skins 34, 36 respectively of thedouble skinned portions 8, 10. The inner and outer skins 34, 36 can be10 gauge sheet polyurethane. The outer skin 36 is then laminated to anouter skin 38 which has the brushed nylon outer surface 26.

As shown in FIGS. 1 and 9, the headwear 2 is provided with holder meansin the form of a long pocket 40. The pocket 40 is for receiving atemperature monitor for monitoring the temperature of the scalp of theperson's head 4. The temperature monitor (not shown) may be connected toa display device (not shown) which may be attached to any suitable partof the person and is preferably attached to the person's waist. Thetemperature monitor and the display device form part of control meansfor controlling the use of the headwear 2.

In order that the invention will be fully understood, reference will nowbe made to the following example.

EXAMPLE

The gel 32 shown was formulated as a 100 gallon mixture (454.6 l) fromthe following ingredients:

1. Fifty gallons (227.3 l) of polypropylene glycol (pharmaceuticalgrade).

2. Seventeen pounds (7711.2 gms) of hydroxypropyl methyl-cellulose.

3. Seven pounds (3175.2 gms) of titanium dioxide.

4. Fifty gallons (227.3 l) of very hot but not boiling water.

The polypropylene glycol, the hydroxypropyl methylcellulose and thetitanium dioxide were mixed together. The water was then added. All thefour ingredients were then continuously thoroughly mixed for 90 minutes.

The polypropylene glycol is employed to enable the gel to remain soft atminus 20° C. The titanium dioxide is used for whitening the gel to giveit a cosmetic look. The hydroxypropyl methylcellulose is a gelling agentwhich enables the formulated gel to store cold energy.

The headwear 2 can be satisfactorily used to reduce scalp temperaturesdown from 31° C. to approximately plus 7° C. in a short space of time.The quick cooling of the scalp temperature is advantageous in that theblood vessels feeding the hair follicles in the scalp quickly constrictand this helps to prevent the cytotoxic alopecia-inducing drugs reachingthe hair follicles. The scalp temperature will start to rise as theheadwear 2 begins to run out of cold energy. The headwear 2 can then beremoved and can be replaced by a new cold article of headwear 2.

It is preferred that the scalp temperature should not rise above 17° C.as otherwise the blood vessels in the scalp tend to dilate and thenallow the cytotoxic drugs to the hair follicles, with resultant hairloss.

Generally, the first article of headwear used may be used for half anhour or three quarters of an hour. This article of headwear may then beremoved and replaced by a fresh cold article of headwear. The secondarticle of headwear may reduce scalp temperatures down to 0° C. and maybe effective to maintain the scalp temperature below plus 17° C. for atleast three quarters of an hour. The length of time that scalp coolingshould be administered is dependent upon the various drugs that are usedfor the chemotherapy and the half life of those drugs.

The above mentioned display device for reading the scalp temperature canbe easily secured to the patient's waist using straps or ties, and caneasily be checked by medical staff at appropriate intervals. If desired,the control means may be arranged to give an audible warning when thescalp temperature approaches 15° C. after the temperature has beenreduced below this figure.

The control means may also include an in-built timer which can be presetfrom half an hour to several hours as a safety backup to a technicalfault developing which would stop the temperature monitor giving itsaudible warning when it senses scalp temperatures approaching 15° C. Inorder to ensure that the headwear 2 is portable, the control means canadvantageously be arranged to run on one or more small batteries. Thecontrol means may be of any suitable and appropriate design so that, forexample, it may have a stiffened wire probe.

It will be appreciated that the initial shape of the headwear 2 as shownin FIG. 1 is very important. This shape enables the headwear 2 to befolded around the person's head 4 as shown in FIGS. 2-8 and to fitequally firmly on small heads and large heads. This is especiallyimportant when it is borne in mind that the headwear 2 will berepeatedly used for patients having different shapes and sizes of heads.The correct degree of compression is important for transferring coldinto the scalp.

Where the headwear 2 has felt or foam insulation, A section of the feltor foam insulation may be removed to give extra cold energy atappropriate points at the back of the head. This is because at the backof the head there are branches of occipital arteries which causehotspots during cooling. The temperature of the blood vessels feedingthe hair follicles at these points tends to rise above 17° C. If thishappens then damage is done to these hair follicles and thinning of thehair or total hair loss occurs at these points.

The headwear 2 may be cooled in air cooled cold storage units which areable accurately to cool lots of articles of the headwear 2, all tosubstantially the same temperature. The cold storage units may haveshelves for receiving the articles of headwear 2. When an article ofheadwear 2 is removed from the cold storage unit, it should be placed ina plastics type freeze box with a lid and the whole box should be takento the patient. The lid can then be removed and the headwear 2 can beplaced on the patient's head. The use of the freeze box helps to retainthe cold in the headwear 2 whilst it is being taken to a patient.

After use, the headwear 2 may be washed in soapy water and dried priorto re-use. When the caps are being cooled, the brushed nylon outersurface 26 should be positioned to the inside so that the inner skin 34is exposed to the cold in the cold storage unit. This enables the gel toabsorb the required cold energy as quickly as possible.

Referring now to FIGS. 11-13, there is shown part of second headwear 2of the invention. Similar parts as in previous Figures have been giventhe same reference numerals.

FIG. 11 shows how the welded seams 29 and 31 form six inter-connectedcompartments (i)-(vi). These compartments help to keep the coldretaining medium evenly distributed over the headwear 2 when it is beingworn and they help to stop the cold retaining medium sagging towards theperson's neck and thus leaving parts of the headwear 2 with none, or aninsufficient amount, of the cold retaining medium.

In FIG. 11, the headwear 2 is shown with a further welded seam 35.

FIG. 12 illustrates how the cold retaining medium 37 is formed in apouch 39 between the weld seams 31, 35. This pouch is domed as can beseen from FIG. 12. However, when the headwear 2 is being worn as shownin FIG. 13, then it will be seen that the pouch 39 has decreased in sizeso that the gel 37 in the pouch 39 is substantially of the samethickness as the gel 37 outside the pouch 39.

It is to be appreciated that the embodiments of the invention describedabove with reference to the accompanying drawings have been given by wayof example only and that modifications may be effected. Thus, forexample, the precise shape of the headwear 2 may vary from that shown inthe drawings. The pocket 40 may be omitted and, for example, up to fivetemperature monitors may be provided is a separate head bandarrangement.

We claim:
 1. Headwear for use in applying cold to a person's scalp,which headwear is flat when it is not being worn, is foldable around aperson's head when it is being worn, and is securable on the person'shead by a plurality of fastener means: the headwear being such that thefolding nature of the headwear and the plurality of fastener meansenables the headwear to be folded as a close fit on the person's headirrespective of different persons with different shapes and sizes ofhead; the headwear being such that it has double skinned portions whichcontain a cold retaining medium which gives up its cold to the person'sscalp when the headwear is being worn, a chin strap, and a layer ofinsulating material for helping to prevent loss of cold from theheadwear to the atmosphere; and the headwear being such that part of theheadwear that covers the back of the head has an extra thickness of coldretaining medium which provides extra cold at the back of the head wherethere are branches of occipital arties which cause hot spots duringcooling of the person's scalp, whereby even cooling all over theperson's scalp is achieved.
 2. Headwear according to claim 1 in whichthe fastener means comprises a plurality of pads of interlockingplastics members, and in which an outer surface of the headwear is suchthat the pads are fastenable to the outer surface, the pads beingpositioned at edge portions of the headwear when it is flat, and theheadwear being such that the pads can be placed where appropriate on theouter surface of the headwear to form the headwear into the requiredshape for fitting closely on the person's head.
 3. Headwear according toclaim 2 in which the outer surface of the headwear is a raised loopedbrushed nylon material.
 4. Headwear according to claim 1 in which thecold retaining medium is polypropylene glycol gel containinghydroxypropyl methylcellulose, titanium dioxide and water.
 5. Headwearaccording to claim 1 and including weld points for use in thinning thecold retaining medium at desired parts of the headwear, the weld pointsbeing so positioned as to thin the cold retaining medium over parts ofthe headwear adjacent the person's forehead and temples, and theheadwear including seams for use in causing the cold retaining mediumevenly to be distributed over the headwear.
 6. Headwear according toclaim 1 in which the insulating material is a foam insulating materialor a felt insulating material.
 7. Headwear according to claim 1 andincluding holder means for a temperature monitor.
 8. Headwear accordingto claim 7 in which the holder means is a pocket.
 9. Headwear for use inapplying cold to a person's scalp, which headwear is flat when it is notbeing worn, is foldable around a person's head when it is being worn,and is securable on the person's head by a plurality of fastener means:the headwear being such that the folding nature of the headwear and theplurality of fastener means enables the headwear to be folded as a closefit on the person's head irrespective of different persons withdifferent shapes and sizes of head; the headwear being such that it hasdouble skinned portions which contain a cold retaining medium whichgives up its cold to the person's scalp when the headwear is being worn,a chin strap, and a layer of insulating material for helping to preventloss of cold from the headwear to the atmosphere; the headwear beingsuch that the double skinned portions are made of a flexible sheetpolyurethane plastics material; and the headwear being such that itcomprises front flaps which connect together to form a part of theheadwear for covering the front of the scalp and the temples, and rearflaps which connect together to form a part of the headwear covering theears, the back of the head and the neck, the rear flaps being such as toinclude a centrally positioned rear flap which is pear-shaped when theheadwear is flat.